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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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IMMULITE®/IMMULITE®1000 Systems PSA PSA Sample Diluent - 00630414954196

PSA Sample Diluent
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10386994
In Commercial Distribution

  • 00630414954196 ()
LPSZ

  • Buffered sample diluent IVD

Atellica IM Calibrator Q - 00630414598451

Calibrator Q - Atellica IM - CAL (6PK) 6 x 2 x 2 mL
Siemens Healthcare Diagnostics Inc.
10995518
In Commercial Distribution

  • 00630414598451 ()
  • 00630414190891 ()
10995518

  • Total prostate specific antigen (tPSA) IVD, calibrator

Atellica IM Calibrator Q - 00630414598444

Calibrator Q Atellica IM - CAL (2PK) 2 x 2 x 2.0 mL
Siemens Healthcare Diagnostics Inc.
10995517
In Commercial Distribution

  • 00630414598444 ()
  • 00630414190884 ()
10995517

  • Total prostate specific antigen (tPSA) IVD, calibrator

IMMULITE®Systems sPS CONTROL Third Generation PSA - 00630414982281

sPS Third Generation PSA Control Module
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10708295
In Commercial Distribution

  • 00630414982281 ()
  • 00630414601793 ()
LUPCM(D)

  • Total prostate specific antigen (tPSA) IVD, control

IMMULITE®/IMMULITE®1000 Systems 3PS Third Generation PSA - 00630414982267

3PS Third Generation PSA Kit 100 Test
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10706293
In Commercial Distribution

  • 00630414982267 ()
LK3PS1(D)

  • Total prostate specific antigen (tPSA) IVD, kit, chemiluminescent immunoassay

IMMULITE® 2000 Systems PTS PSA - 00630414982229

PTS PSA Kit 600 Test
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10706282
In Commercial Distribution

  • 00630414982229 ()
L2KPTS6(D)

  • Total prostate specific antigen (tPSA) IVD, kit, chemiluminescent immunoassay

IMMULITE® 2000 Systems PTS PSA - 00630414982212

PTS PSA Kit 200 Test
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10706281
In Commercial Distribution

  • 00630414982212 ()
L2KPTS2(D)

  • Total prostate specific antigen (tPSA) IVD, kit, chemiluminescent immunoassay

IMMULITE®/IMMULITE®1000 Systems PTS PSA - 00630414982205

PTS PSA Kit 100 Test
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
10706279
In Commercial Distribution

  • 00630414982205 ()
LKPTS1(D)

  • Total prostate specific antigen (tPSA) IVD, kit, chemiluminescent immunoassay

RECELL GO mini - 00851707004361

RECELL GO mini Autologous Cell Harvesting Device (Preparation Kit)
AVITA MEDICAL AMERICAS, LLC
AVRL0105
In Commercial Distribution

  • 00851707004361 ()


  • Autologous skin cell grafting kit

RECELL GO - 00851707004286

RECELL GO Autologous Cell Harvesting Device (Preparation Kit)
AVITA MEDICAL AMERICAS, LLC
AVRL0103
In Commercial Distribution

  • 00851707004286 ()


  • Autologous skin cell grafting kit
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